For Patients

Extina (ketoconazole foam, 2%) is used to treat fungal infections of the skin such as athlete's foot, jock itch, ringworm, and seborrhea (dry, flaking skin). It is a topical (for the skin) antifungal medication. This medication is available in generic form. Common side effects include burning or irritation at the application site.

The recommended dose of Extina Foam is to apply to the affected area(s) twice daily for four weeks. Other drugs may interact with Extina. Tell your doctor all medications and supplements you use. During pregnancy, Extina should be used only when prescribed. It is unknown if this drug passes into breast milk when applied to the skin. Consult your doctor before breastfeeding.

Our Extina (ketoconazole foam, 2%) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

SIDE EFFECTS: Burning or irritation at the application site may occur. If either of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

SIDE EFFECTS

Adverse Reactions in Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse
reaction rates observed in the clinical trials of a drug cannot be directly
compared to rates in the clinical trials of another drug, and may not reflect
the rates observed in practice. The adverse reaction information from clinical
trials does, however, provide a basis for identifying the adverse reactions
that appear to be related to drug use and for approximating rates. The safety
data presented in Table 1 (below) reflect exposure to Extina (ketoconazole foam, 2%) Foam in 672 subjects,
12 years and older with seborrheic dermatitis. Subjects applied Extina (ketoconazole foam, 2%) Foam
or vehicle foam twice daily for 4 weeks to affected areas on the face, scalp,
and/or chest. Adverse reactions occurring in > 1% of subjects are presented
in Table 1.

Application site reactions that were reported in ≤ 1% of subjects were dryness,
erythema, irritation, paresthesia, pruritus, rash and warmth.

Dermal Safety Studies

In a photoallergenicity study, 9 of 53 subjects (17%) had reactions during
the challenge period at both the irradiated and non-irradiated sites treated
with Extina (ketoconazole foam, 2%) Foam. Extina (ketoconazole foam, 2%) Foam may cause contact sensitization.